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Pagoda

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name
Pagoda FDA UDI
Generic Name
Spinal bone set screw FDA UDI
Device Name
Set Screw FDA UDI
Model / Reference
752-0004 FDA UDI
Description
Set Screw FDA UDI

Identifiers

Primary DI / UDI-DI
00822409027705 FDA UDI
510(k) Number
K131785 FDA UDI
FDA Product Code
MNH FDA UDI
MNI FDA UDI
NKB FDA UDI
GMDN Term
Spinal bone set screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Pagoda by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K131785 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Development Corp.

Sources (1)

  • FDA UDI 7899a407-1526-4a9f-923a-522d20a3708c 36 fields · synced Jun 1, 2026